Genentech's Fenebrutinib Is the First BTK Inhibitor to Receive U.S. FDA Filing Acceptance in Both Relapsing and Primary Progressive Multiple Sclerosis

The FDA accepted the filing for fenebrutinib, an investigational BTK inhibitor, for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The acceptance advances the drug into regulatory review and represents a positive catalyst for its developer, though approval, timing, and commercial potential remain uncertain.